RegeneRx Announces First Patients Enrolled in Phase 3 U.S. Dry Eye Clinical Trial (ARISE-2 Trial) with RGN-259

ROCKVILLE, Md., Nov. 9, 2016 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, announced today that the first patients have been enrolled in a Phase 3 clinical trial (ARISE-2 trial) with RGN-259 (Thymosin beta 4), its sterile, preservative-free eye drop formulation developed for patients with dry eye syndrome, neurotrophic keratopathy (NK), and other corneal disorders.

The primary endpoints of the ARISE-2 trial are the change in ocular discomfort and the change in inferior corneal staining at baseline (prior to first dose) and at the end of treatment (after last dose) in a controlled adverse environment (CAE^®).  They are the same efficacy assessments under CAE^® that showed strong statistical significance in the Phase 2b/3 trial (ARISE-1) that was reported earlier this year.

The double-masked, placebo-controlled trial is being sponsored by ReGenTree LLC, a joint venture between RegeneRx and GtreeBNT Co. Ltd. a Korean biopharmaceutical company and is being conducted by Ora Inc., an established contract research organization specializing in the field of ophthalmology.  ARISE-2 is being conducted at multiple sites in the U.S., will enroll approximately 500 dry eye patients, and is expected to be completed and patient data reported in Q4 2017. There will be numerous secondary endpoints and other safety and efficacy parameters that will also be evaluated pursuant to the trial protocol.   

"The start of this second trial, which we've named "ARISE-2," is another significant milestone for RegeneRx and our U.S. joint venture, ReGenTree, LLC.  Our partners at GtreeBNT have done an excellent job diligently moving RGN-259 into late stage clinical trials, which also necessitated conducting numerous ancillary projects required by government regulations that are less visible but quite comprehensive in scope. We expect ARISE-2 to be completed during Q4 2017 and look forward to reporting material events along the way," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.

Thymosin beta 4 (Tβ4), the  active ingredient in RGN-259, is a first-in-class, naturally occurring molecule that has been the subject of numerous published animal studies in the fields of ophthalmology, dermatology, cardiology, and central nervous system disorders, among others. In addition to the animal studies, the molecule has been tested in three unique formulations and routes of administration in approximately 650 patients and has an excellent safety profile.

About RGN-259 (GBT-201) for the Treatment of Dry Eye Syndrome

RGN-259 (designated GBT-201 in Korea) is a sterile, preservative-free topical eye drop for ophthalmic indications whose active ingredient is Thymosin beta 4 (Tβ4). Based on U.S. Phase 2 and Phase 2b/3 clinical trials in moderate and severe dry eye syndrome, RGN-259 was found to show statistically significant improvements in several signs and symptoms of dry eye, as well as positive trends in other outcome measures.  The data from these trials, as well as a previously completed clinical trial of RGN-259 in patients with NK, reflect RGN-259's mechanisms of action, support the "protective" effects of RGN-259, and provide RegeneRx with FDA-approvable clinical endpoints to be targeted in future clinical trials.  Dry eye syndrome is a multifactorial disease and it is well known that Tβ4 promotes cell migration and proliferation, modulates cytokines and/or chemokines related to inflammation, matures stem cells, and stimulates cell survival, all of which are believed to be important for effective treatment of DES.

About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)

RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tβ4) and its constituent fragments, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and has patents and patent applications covering its products in many countries throughout the world. RGN-259, the Company's Tβ4-based ophthalmic drug candidate, has been designated an orphan drug in the U.S. for the treatment of neurotrophic keratopathy (NK). In March 2016, RegeneRx, through its U.S joint venture, ReGenTree LLC, completed a 317-patient Phase 2b/3 clinical trial in patients with dry eye syndrome. The dry eye trial results were announced in May 2016 and ReGenTree has subsequently received permission from the U.S. FDA and initiated a second Phase 3 trial in approximately ~500 patients. The Company is simultaneously conducting a 46-patient Phase 3 clinical trial in patients with NK. RGN-259 is also being developed in patients with dry eye syndrome in Asia through RegeneRx's two Asian partnerships. RGN-352, the Company's Tβ4-based injectable formulation, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and repair cardiac damage resulting from heart attacks and central nervous system tissue damage associated disorders such as multiple sclerosis and traumatic injuries such as stroke. For additional information about RegeneRx please visit www.regenerx.com.

About ReGenTree LLC

ReGenTree is a U.S. joint venture company owned by G-treeBNT Co., Ltd, and RegeneRx Biopharmaceuticals, Inc. specifically to develop RGN-259/GBT-201 in the U.S. for ophthalmic indications.  ReGenTree licensed the rights to RGN-259 from RegeneRx in 2015 and completed a Phase 2b/3 and Phase 3 clinical trials in patients with dry eye syndrome in 2016.  ReGenTree is also sponsoring a Phase 3 clinical trial in patients with neurotrophic keratopathy (an orphan indication) that was initiated in September 2015.  Results from the trial are expected by the end of 2017.  RegeneRx retains a significant minority interest in the joint venture, along with a royalty on commercial sales, and is represented on the board of ReGenTree.  Certain commercial and financial transactions require RegeneRx approval.  G-treeBNT is responsible for operations of the venture and all funding required for clinical development of RGN-259/GBT-201 in the U.S.

Forward-Looking Statements

Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Forward-looking statements used in this press release relate to, among other things, the expected timing of initiation and completion clinical trials in the United States and the potential benefits to RegeneRx of such trials. There can be no assurance that any proposed clinical trial will start within the estimated initiation timeframe or be completed within the estimated timeframe or that positive results from any clinical trials or research by the Company, its collaborators, or independent parties in the U.S. or any other country will result in subsequent clinical confirmation or future value. There can also be no assurance that any of the Company's drug candidates will result in any approved products in the U.S. or any other country. Please view these and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" section of the annual report on Form 10-K for the year ended December 31, 2015, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.

SOURCE RegeneRx Biopharmaceuticals, Inc.